Orthopedic and dental implant system and method

ABSTRACT

A system for removing osteal cement and prosthetic joint components in connection with a prosthetic joint revision includes a controller connected to and controlling operation of a transducer, such as a surgical saw or drill. A tool mounted on the transducer is adapted for engaging the prosthetic joint cement mantel and melting an engagement portion of same. The cement in the engagement portion is resolidified with the tool tip embedded therein. The tool thus bonds to the cement mantel, and is used for vibrating, softening and breaking up same when operation of the transducer resumes. An osteal cement and prosthetic device removal method includes the steps of melting an engagement portion of the osteal cement mantel, bonding a transducer-mounted tool to the cement mantel by resolidifying the cement engagement portion and reactivating the transducer for vibrating, softening and breaking up the cement mantel whereby it can be removed from the patient.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to implant systems and methodsfor orthopedic and dental applications. More specifically, the presentinvention relates to implant insertion and extraction with couplings forattachment to manual and power force transducers with control over forcevariables.

2. Description of the Related Art

Many orthopedic procedures involve implants for replacing damaged anddysfunctional joints. For example, total joint replacement (TJR) andhemi arthroplasty (replacing one-half of the joint) procedures have beendeveloped. Hips, knees, elbows, shoulders and wrists are commonlyreconstructed with implants, such as prosthetic joints that are designedfor optimal wear, comfort, biocompatibility and performance. Suchreplacement joint implants have benefited many patients by restoringtheir mobility and other functions.

Reconstructive dental procedures include installing implants such asprosthetic teeth, bridges, mandibles, temporomandibular (TMJ) joints andother dental prostheses. Significant improvements in dental function canbe achieved for many patients using such procedures.

An important objective in designing orthopedic and dental implants andin performing implant procedures relates to effectively and permanentlybonding the prosthetic components to patients' existing, viable bone anddental structure. For example, TJR orthopedic surgery typically involvesremoving damaged and degenerated existing joints and adjacent bonestructure for replacement with prostheses. The remaining bone structureis preferably sound, dense and capable of withstanding dynamic loads inorder to maximize patient function and mobility. A general objective oforthopedic and orthodontic surgery is to retain as much original,healthy bone structure as possible.

Orthopedic and orthodontic revision procedures are necessitated byprosthetic failures from various causes. For example, furtherdeterioration and trauma can lead to prosthetic joint failures. Anotherproblem relates to loosening and disengagement of the components. Forexample, orthopedic cement, which is commonly used to bond prostheticcomponents to bone, can loosen and disengage. Looseness and “play” inimplants, such as prosthetic joints, can cause significant problems.These include patient discomfort and immobility. Moreover, suchlooseness can increase under dynamic loading, and can ultimately lead tocomplications associated with implant failure.

When revision procedures are indicated by such conditions, extractingexisting implants and the cement mantels bonding same can presentsignificant difficulties. Extracting prostheses that have beenpermanently bonded in place with high-strength adhesives can requiresubstantial force, with resulting trauma and collateral damage. Forexample, perforated and cracked existing bone structures can result fromforces associated with extracting failed prostheses.

Moreover, implants can become stuck during installation. For example, ifthe cavity formed for the implant shaft is too small, a test fit canresult in immobility with resistance to both insertion and extraction.Extracting a stuck implant can require breaking the surrounding bonestructure, with resulting complications.

The prior art has attempted to address some of the problems associatedwith orthopedic implant extractions. For example, the Engelbrecht et al.U.S. Pat. No. 4,248,232 discloses the use of a vibrating tool to softenthe cement between nested components bonded together. The Hood et al.U.S. Pat. No. 5,045,054 discloses an ultrasound power generator adaptedfor coupling to endoprostheses and vibrating same to soften theiradhesive bonds. Hood et al. disclose an ultrasonic tool for attachmentto and removal of surgical components in U.S. Pat. No. 5,318,570.Vandewalle et al. U.S. Pat. No. 6,190,392 disclose an auger toolconnected to an ultrasonic transducer/handpiece for extracting an ostealcement mantel.

Heretofore there has not been available an orthopedic and dental implantsystem and method with the advantages and features of the presentinvention.

SUMMARY OF THE INVENTION

In the practice of the present invention, systems and methods areprovided for installing and extracting orthopedic and dental implants.In one aspect of the invention, a manual or power force transducer iscoupled to an implant for imparting installation or extraction forces,ranging from low-amplitude vibrations to impact blows through a range offrequencies. The forces can act in either direction, i.e. insertion orextraction, or both in an alternating operational mode. The amplitudesof the forces can be varied, including amplitude differentials oninsertion/extraction strokes. The forces can be linear reciprocating,rotorary reciprocating, oscillatory (side-to-side) or orbital.

In another aspect of the invention, a power source connects to a workingtip adapted for melting an engagement portion of a cement mantel.Discontinuing the application of power to the working tip causes thecement to resolidify on and capture same. A second power applicationvibrates the entire homogenous portion of the cement loose forextraction.

In another aspect of the invention, the controller scans predeterminedfrequency, amplitude and other variable ranges and selects optimumvalues for such operating parameters based on feedback received fromsensors connected to vibrating tools or patients. The sensors can detectcurrent loading as a function of variable patient and system conditions.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings constitute a part of this specification and includeexemplary embodiments of the present invention and illustrate variousobjects and features thereof.

FIG. 1 is a schematic, block diagram of an implant system embodying thepresent invention.

FIG. 1A is a perspective view of a hip femoral implant.

FIGS. 2-9 are fragmentary views of the coupling in the process ofattachment to the implant.

FIGS. 10-12 are fragmentary views of a coupling embodying another aspectof the invention, showing the process of attachment to the implant stem.

FIG. 13 is a top plan view of the coupling and the implant, takengenerally along line 13-13 in FIG. 12.

FIG. 14 is a top plan view of the coupling and the implant, with thecoupling compressed onto the implant stem.

FIG. 15 is a block diagram of an automated system embodying anotheraspect of the present invention.

FIG. 16 is a flowchart showing an aspect of the method of the presentinvention.

FIGS. 17-18 are cross-sectional views of a femur, showing an aspect ofthe method of the present invention for removing an orthopedic cementmantel from the intramedullary canal.

FIGS. 19-22 are vertical, cross-sectional views of a femur, showing theremoval of a femoral implant and the cement mantel associated therewithaccording to an aspect of the method of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

I. Introduction and Environment

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which may be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure.

Referring to FIG. 1, the reference numeral 2 generally designates anorthopedic and dental implant system embodying an aspect of the presentinvention. The system 2 generally includes an external subsystem 3including a force transducer 4, which can comprise a manual device, suchas a slaphammer, or an electrical, pneumatic or hydraulic power device.The transducer 4 is adapted for variable operation, including suchvariable operating parameters as frequency, amplitude, direction (i.e.in or out with respect to the patient) and insertion and/or extraction.The transducer 4 can apply linear reciprocating, rotary reciprocating,oscillatory (side-to-side) or orbital force. A coupling 6 is connectedto the force transducer 4. The coupling 6 and its ancillary componentscan be disposable for one-time usage in conjunction with a TMJ or otherprocedure, or they can be adapted for sterilization and reuse.

A patient subsystem 5 includes an orthopedic or dental implant 8, whichis adapted for placement in a patient 12 with an interspace 10therebetween, which can receive suitable orthopedic cement for bondingthe implant 8 in place.

FIG. 1A shows a femoral implant 15, which can be used in a hip jointreplacement procedure. The implant 15 includes an intramedullary canalshaft 17 integrally formed with a head 19 including a transverse passage20. The shaft 17 can be finished with a scratch fit texture or engravingto facilitate bonding to bone. A stem 22 projects upwardly at an obliqueangle from the head 19 and mounts a spherical cap 24 on a Morse taper25. The cap 24 is pivotably received in an acetabular cup (not shown) toform a ball-and-socket type hip joint. Various configurations anddesigns of femoral and other implants can be used with the system of thepresent invention.

Transducer-To-Implant Couplings

FIG. 2 shows a distal end 26 of the coupling 6 with a clevisconfiguration including a pair of receivers 28 with hexagonal recesses30, which are adapted for alignment with the passage 20 (FIG. 3). FIG. 4shows a guide wire 32 forming a loop 34 extending through the implantpassage 20 and the coupling receivers 28. The loop 34 can be capturedwith a suture 36, which can be inserted into the patient from an entrylocation spaced from the entry location for the guide wire 32. FIGS. 5and 5A show a flexible guide extension member 38, which tapers from amaximum diameter at a female-threaded base 40 to a minimum diameter at apointed tip 42 with an eyelet 44. The guide member 38 is adapted forpulling a fastener, such as a bolt 46, through the aligned implantpassage 20 and the clevis end receivers 28. The bolt 46 is threadablyreceived in the guide member base 40 and the guide member eyelet 44receives the guide wire 32, which is adapted for pulling the guidemember 38 (FIG. 5). The flexibility of the guide member 38 enables it toapproach the passage 20 and the receivers 28 from oblique angles.

FIG. 6 shows the bolt 46 in place, with the guide member 38 extendingtherefrom. The bolt 46 includes a bolt loop 48 extending from itsthreaded end and adapted to capture the guide wire 32 or a suture toprovide an alternative or auxiliary technique for installing the bolt46. A nut 50 is threadably received on the end of the bolt 46 and can bedrawn into the hexagonal recesses 30 (FIGS. 7 and 8), or surface-mountedon the clevis 26 (FIG. 9) with a washer 52.

The coupling distal, clevis end 26 transmits force from the forcetransducer 4 to the implant 8, as shown by the double-ended force arrow54 (FIG. 8), which represents the application of linear, reciprocating“in” strokes 14, “out” strokes 16, or both (FIG. 1). As noted above,such forces can also be rotary reciprocating, oscillatory (side-to-side)or orbital. In operation such forces can be applied as necessary by thephysician installing or extracting the implant 8. Moreover, test fittingsame is facilitated with reduced risk of the implant becomingirretrievably stuck in an overly-tight intramedullary canal.

FIGS. 10-14 show an alternative configuration coupling distal end 60comprising another aspect of the invention. The coupling end 60 has aclevis configuration with a shaft 62 extending at an oblique angletherefrom and connected to the force transducer 4. The coupling end 60receives the implant stem 22 below a frusto-conical cap thereof and isclamped thereon (FIGS. 13-14) by a fastener, which can comprise a boltreceived in coupling end receivers 66 and including hexagonal recessesfor the bolt head 70 and a nut 72 (FIGS. 11 and 12), as required. Awasher 74 can also be provided on either or both sides of the couplingend 60. As shown in FIG. 14, the coupling end 60 is deformable in orderto securely clamp the implant stem 22.

Orthopedic Cement Extraction System and Method

A system 102 and a corresponding method comprising an alternative aspectof the present invention are shown in FIGS. 15-22 and are adapted forinstalling and removing orthopedic and dental implants 103 andorthopedic cement 104. Implants are commonly bonded in place withorthopedic cement, which may require removal in connection with revisionprocedures. For example, femoral implants are inserted intointramedullary canals and secured therein by cement.

Orthopedic cement 104 is placed in an interspace 130 around the implant103 within the intramedullary canal of a bone 105 in a patient 107.Although an exemplary application of the invention is described inconnection with a hip TJR, applications for same are virtually unlimitedand include other replacement joints, such as knees, shoulders, etc.

The system 102 generally includes a controller 116 including aprogrammable microprocessor 118. The controller 116 can include variouscomponents, such as input and output devices, memory storage, etc. Afoot pedal switch assembly 120 is connected to the controller 116 forproviding input thereto and includes frequency and amplitude controlswitches 122, 124, which are adapted for hands-free operation by anoperator pressing same with his or her feet, for example in a sterileoperating environment.

A transducer 126 is controlled by the controller 116 and is operablyconnected to a tool 127 for imparting mechanical energy to the implant103 and/or the cement 104. For example, the transducer 126 can providerotorary reciprocating, linear reciprocating, oscillatory(side-to-side), orbital and other types of motion. The tool 127 cancomprise a coupling, as described above, or various reciprocating andoscillatory saws, which are suitable for use with the system 102. Othertypes of tools include drills, vibrators and reciprocating chisels. Thetool 127 is preferably designed for engaging the implant 103 or cutting,forming or shaping the cement 104, and can be used for dynamicallycoupling the transducer 126 to the implant 103 and/or the cement 104. Apower source 128 provides power to the transducer 126 and can becontrolled by the controller 116. The power source 128 can compriseelectrical power, compressed air, compressed nitrogen, hydraulic fluid,etc.

The microprocessor 118 receives input signals from sensors 109, 111,113, 115, 117 and 119 connected to the system components as shown inFIG. 1. For example, sensors 109, 111 provide feedback from thetransducer 126 and the tool 127 respectively. The sensors 113, 115, 117and 119 provide feedback from the implant 103, the cement 104, the bone105 and the patient 107 respectively. It will be appreciated that feweror more sensors can be utilized with the present invention, and canmonitor and provide feedback with respect to the operation of varioussystem components and the operating parameters associated with same. Forexample, the power load on the transducer 126 can be sensed for reactionby the controller 116, if necessary. Similarly, patient conditions suchas temperature, blood pressure, stress indicators, etc. can be monitoredand the microprocessor 118 can be preprogrammed to react to particularpatient conditions and control the appropriate operating parameters ofthe system 102 whereby the primary functions thereof can be automated.

One or more of the sensors can comprise an energy-sensing device, suchas an infrared thermal sensor. The controller 116 can be configured forthermally mapping the joint area whereby the temperature changes in theprosthetic joint 106, the patient 107 and the cement mantel 104 can bemonitored in real-time. Such a thermal map can be displayed on a monitor125 connected to the controller 116, which processes the thermalcharacteristics detected by the infrared thermal sensor as input forautomatic control functions by the controller 116 and/or visualobservation by means of the monitor 125.

Orthopedic Cement and Implant Extraction Method

FIG. 16 is a flowchart of a method embodying the present invention. Fromstart 132 a patient 107 is prepared at 134 and the controller 116 isinitialized at 136. Initializing the controller can includepreprogramming certain operating parameters and conditions. For example,various common prostheses can be accommodated by preprogramming thecontroller to operate the transducer 126 at presumed optimum conditions,subject to varying the output signals to correspond to the actualconditions encountered. The existing joint 6 is accessed at 138 and theexisting mass or mantel of cement 4 is exposed at 140.Polymethylmethacrylate (PMMA) cement is commonly used for implantattachment, particularly in medullary canals. Such cement is susceptibleto softening when vibrated in the ultrasonic range, and tends to reformand reharden when the energy application is discontinued. The transducer126 is activated at 141 and operates at a first frequency f1 and a firstamplitude A1.

Accordingly, an engagement portion of the cement mantel 104 is melted at142 and the tool 127 is embedded therein at 144. The melted engagementportion resolidifies at 146, thereby bonding the tool 127 to the cementmantel 104. The transducer 126 operates at a second frequency f2 and asecond amplitude A2 at 148. For example, low-frequency vibration can beutilized to extract the cement. Feedback is received at 150. Suchfeedback can be derived from the various sensors 109, 111, 113, 115,117, 119 and can correspond to such conditions as temperature andtransducer current flow (corresponding to load conditions). For example,greater cement resistance to vibration can cause a greater load on thetransducer 126, which in turn causes the current flow to increase. Suchchanging conditions can be sensed and predicted and can cause thecontroller 116 to respond accordingly. For example, upon encounteringlessening resistance due to the cement mantel 104 softening, thecontroller 116 can reduce the amplitude of the energy applied to thetransducer 126. Moreover, the resonant frequency of the components canbe monitored. Frequency and amplitude changes can thus be detected andreacted to, for example by reducing or discontinuing the application ofpower.

It will be appreciated that the microprocessor 118 can be programmed toprovide appropriate reactions to accommodate various operationalparameters. For example, it is generally desirable to avoid excessiveheat, which can damage both bone and soft tissue, thereby prolongingpatient recovery. The microprocessor 118 can thus be programmed toreduce or cut off transducer power upon detecting certain conditions atany of several locations in the prosthetic joint or the patient.Moreover, manual inputs from the foot pedal switches 122, 124 or otheroperator-controlled inputs can be coordinated with automatic controlfeatures. For example, the operator can manually adjust such operatingparameters as amplitude and frequency within predetermined operatingranges, beyond which automatic controls take over to avoid potentialharm or discomfort to the patient.

If a frequency adjustment is indicated at decision box 152, thecontroller provides another frequency (f_(n+1)) at 154, and returns tothe feedback step 150. When no further frequency adjustment is needed(negative branch from decision box 152), the method proceeds to lock infrequency at 156. Another feedback step occurs at 158 and leads to anamplitude adjustment decision box at 160, from which a positive decisionleads to the next amplitude (A_(n+1)) being generated at 162. Thenegative branch from the decision box 160 leads to a lock in amplitudestep at 164. Extraction occurs at 166, the joint is revised at 168 andthe method terminates at 170.

FIGS. 17-18 show applications of the cement removal system 102 and themethod described above in connection with removing a cement mantel 170from the intramedullary canal 172 in a femur 174. The mantel 170 issegmented with cuts 176. The blade 178 forms an engagement portion 180whereat the liquefied cement 170 is permitted to solidify on the blade178. The respective segments 182 can thus be extracted with thecontrolled application of force, such as low-frequency vibration, asshown in FIG. 18.

FIG. 19 shows a femur 210 and a femoral implant 208, which are separatedby an interspace 230 filled with orthopedic cement 204. FIG. 20 showsthe implant 208 removed, leaving the cement 204 within theintramedullary canal 206. As shown in FIG. 21, the tool 227 haspenetrated an engagement portion 232 of the cement 204, whichresolidifies to capture same. FIG. 22 shows a chunk 234 of cement 204being removed from the intramedullary canal 206. By properly adjustingthe frequency and amplitude of the transducer 126, substantial portionsof the cement 204 can be removed. Upon completion of the extractionprocedure, the walls of the intramedullary canal 206 are preferably freeof cement 204, as shown in FIG. 22. The treating physician can thenproceed with the revision procedure, including installation ofreplacement prosthetic components.

Although the system 102 and its methods of use have been described inconnection with computer-controlled automation, the methods of thepresent invention can be practiced manually.

It is to be understood that while certain embodiments and/or aspects ofthe invention have been shown and described, the invention is notlimited thereto and encompasses various other embodiments and aspects.

1. An orthopedic or dental implant system, which comprises: a force transducer adapted for applying an insertion and/or extraction force; a coupling connected to said force transducer and adapted for transmitting a force provided thereby; an implant including an interface for connection to a patient's dental or bone structure and a coupling engagement adapted for releasable, force-transmitting connection to said coupling; and force control means for varying the force applied by said transducer.
 2. The system according to claim 1, wherein said coupling includes a proximate end connected to said force transducer and a distal end with a clevis configuration adapted for selectively clamping said implant engagement.
 3. The system according to claim 2, which includes: a mechanical fastener adapted for mounting on and securing said coupling distal end on said implant.
 4. The system according to claim 3, which includes: a pair of receivers in said distal clevis end, which are adapted for selectively receiving said mechanical fastener; a flexible guide member with a base adapted for releasable connection to said mechanical fastener and a tip adapted for passing through said clevis end receivers; and said guide member being adapted to place said mechanical fastener in said clevis end receivers.
 5. The system according to claim 4, which includes: said implant engagement including a passage adapted for alignment with said clevis end receivers and for receiving said mechanical fastener; a guide wire adapted for passage through said aligned receivers and passage and for releasable connection to said guide member tip; and said guide member having a tapered configuration with a maximum diameter at its base and a minimum diameter at its tip; said guide member having a female-threaded receiver open at its base; and said mechanical fastener having a male-threaded end adapted for being received in said guide member base receiver with said guide member connected to said fastener.
 6. The system according to claim 2 wherein: said implant includes a stem projecting outwardly therefrom; said coupling clevis end is adapted for deformable, clamping engagement partially around said stem; and said coupling includes a shaft extending from said force transducer and connected to said clevis end at an oblique angle.
 7. The system according to claim 2 wherein said coupling end includes a pair of hexagonal recesses each adapted for receiving a hexagonal bolt head or a hexagonal nut.
 8. The system according to claim 1 wherein said force transducer comprises a slaphammer.
 9. The system according to claim 1 wherein said force transducer comprises a double-acting device powered by a power source selected from the group consisting of electrical, pneumatic and hydraulic and including a controller adapted to vary the amplitude and frequency operating parameters of the device.
 10. The system according to claim 1 wherein said force transducer provides an output force with a motion characterized by one of the group comprising rotorary reciprocating motion, linear reciprocating motion, oscillatory motion and orbital motion.
 11. An orthopedic or dental implant method, which includes the steps of: providing a power force transducer with variable amplitude, frequency and directional operating parameters; providing a power source chosen from among the group consisting of electrical, pneumatic and hydraulic power and selectively applying same to said transducer; providing a controller including a microprocessor connected to said transducer; preprogramming said microprocessor to control said transducer operating variables in response to predetermined conditions; providing a coupling with a proximate end operably connected to said force transducer and a distal end; providing an implant with a bonding portion adapted for bonding to a patient's bone structure and an engagement portion adapted for connection to said coupling; providing a cement-filled interspace between said implant and said patient bone structure; releasably connecting said coupling distal end to said implant engagement portion; applying a first vibratory force with a first set of said parameters from said transducer to said implant through said coupling; providing a sensor connected to said controller and to said patient or said implant; producing a signal with said sensor corresponding to a condition of said patient or said implant; receiving said signal with said controller; providing a second vibratory force from said force transducer through said coupling to said implant; altering said transducer operating parameters according to said sensor signal to provide a second set of transducer operating parameters; and installing or extracting said implant with respect to said patient by the application of said vibratory force.
 12. A system for installing or extracting orthopedic or dental implants or cement from the bone structure of a patient, which system comprises: a controller including an input adapted for receiving input signals and an output; an input device adapted for providing an input signal to said controller; a transducer connected to said controller output and adapted for providing a repeating, variable motion in response to an output signal from said controller; a tool connected to said transducer and adapted for fixedly engaging said implant or said cement; said controller varying said output therefrom in response to inputs thereto, said controller inputs corresponding to operating conditions of said system; and said transducer and said tool being adapted for vibrating and installing or dislodging said implant or said cement from said patient bone structure.
 13. The system according to claim 12, which includes: said transducer having variable direction, frequency and amplitude, which are variably controlled by said controller.
 14. The system according to claim 12 wherein said input device is manually operated.
 15. The system according to claim 12 wherein said input device comprises a foot pedal assembly with controls adapted for adjusting frequency and amplitude.
 16. The system according to claim 12, which includes: a sensor connected to said patient and/or said transducer, said sensor being adapted to detect a condition associated with said patient and/or said transducer; said sensor being connected to said controller input and providing said input signals thereat; and said controller being adapted to automatically vary the operating parameters of said transducer in response to controller input signals from said sensor.
 17. The system according to claim 12 wherein said controller is adapted for automatically varying the frequency and amplitude of said transducer and is further adapted for locking in an optimum frequency and amplitude for installing or extracting said implant or said cement.
 18. An orthopedic implant revision method, which comprises the steps of: exposing the intramedullary canal; extracting the existing implant; providing a transducer with a cement-working tool; segmenting the orthopedic cement within the intramedullary canal; operating the transducer with the tool engaging a portion of the cement; melting said engagement portion of said cement mantel with said tool; extending a tip of said tool into said molten or softened cement mantel engagement portion; pausing the transducer operation; resolidifying the cement engagement portion of the cement mantel with the tool tip embedded therein; resuming operation of the transducer; breaking the bond between the cement and the patient's bone structure with the transducer; removing the cement from the patient; and installing the replacement implant. 